Manager, Quality Operations

Gilead Sciences

Manager of Quality Operations in CAR-T cancer immunotherapy at Kite Pharma. Collaborating cross-functionally for apheresis collection and treatment centers in the expanding cell therapy product area.

Posted 4/30/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $123,930 - $160,380 per yearWebsite

About the role

Key responsibilities & impact

Assess and approve any changes to Apheresis Collection Module, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained.
Assist in the management of an apheresis and treatment center (ATC) qualification process using risk-based tools for qualification, training, monitoring and disqualification.
Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
Perform a variety of audits, qualify and monitor compliance to qualification requirements.
Maintain the monitoring schedule and approved ATC list.
Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
Support and/or own quality records (Deviations, CAPA, Change control, etc.)
Assist in development, implementation and management of ATC management system (GVault)
Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
Ability to travel up to 40%

Requirements

What you’ll need

Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience OR PhD / PharmD
Bachelor’s degree in biological sciences, nursing, medical technologist or related field
8 years progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles.
Minimum 3-5 years quality assurance experience preferred
Experience managing external suppliers, blood banks, and plasma centers.
Medical center or pharmaceutical auditing experience preferred.
Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
Previous experience in deviation management, development of corrective preventive/actions and change control, preferred.
ASQ Certified Quality Auditor preferred
Strong working knowledge of and the ability to apply GMP and FACT/AABB standards
Previous experience presenting and responding to regulatory agency or certification audits, preferred
Proficient in MS Word, Excel, and Power Point
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Must be able to work independently, can multi-task and prioritize job responsibilities
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

Benefits

Comp & perks

company-sponsored medical, dental, vision, and life insurance plans.
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality assurancedeviation managementcorrective preventive actionschange controlauditingrisk-based toolsGMPFACT standardsAABB standardsclinical research

Soft Skills

interpersonal skillsverbal communicationwritten communicationself-motivateddetail-orientedmulti-taskingprioritizationcollaborationadaptabilityindependence

Certifications

ASQ Certified Quality Auditor